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Completed

NCT Number: NCT02022774

Efficacy of fimaSartan on arTerIal stiFFness iN patiEntS With HypertenSion

The purpose of this study is to evaluate the effects of fimasartan on arterial stiffness in patients with hypertension

Completed

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Carollo Hospital, Suncheon, Jeollanamdo, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects who agree to participate in this study and give written informed consent
  • Subjects whose sitting diastolic blood pressure measured at placebo visit and baseline are more than 90 mmHg and/or systolic blood pressure are more than 140 mmHg
  • Subjects who are naive to anti-hypertensive treatment
  • Subjects considered to understand the study, be cooperative, and able to be followed-up until the end of the study

Exclusion criteria

  • Subjects who are hypersensitive to angiotensin type 1-receptor blockers
  • Subjects with secondary hypertension
  • Subjects with severe hypertension (systolic blood pressure >= 180 mmHg OR diastolic blood pressure >= 110)
  • Severe cardiac disease (heart failure, ischemic heart disease, peripheral vascular disease, moderate valvular disease, arrhythmia requiring treatment, cardiomyopathy, etc.)
  • Subjects with chronic obstructive pulmonary disease or history
  • Clinically significant renal dysfunction (Creatinine 2.0 mg/dL) and liver dysfunction (ALT, AST > 2x UNL)
  • Subjects with life expectancy of less than 2 years due to non-cardiac disease
  • Subjects with history or evidence of abuse of drugs or alcohol within 2 years
  • Severe insulin-dependent diabetes mellitus or intractable diabetic patient (dose/regimen change of oral hypoglycemic agent, insulin use)
  • Severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, within 6 months)
  • Wasting diseases, autoimmune diseases (rheumatoid arthritis, systemic lupus anticoagulants, etc.), history of connective tissue disease or ongoing disease.
  • Women with pregnancy and breast feeding
  • Women planning to be pregnant or without admitted contraception despite of probability of pregnancy (Women who underwent sterilization operation are excluded. Fertile women without such surgery should undergo pregnancy test and can participate only with negative result. Intermittent abstinence like basic body temperature method, natural period method are not considered admitted contraception and no hormonal contraception is allowed.).
  • Subjects who are participating in other clinical trials for investigating agents or have taken other clinical trial medication within 4 weeks before screening visit.
  • Subjects judged to be inappropriate by the investigator

Treatment and study plan

Fimasartan

Drug

Fimasartan 60 ~ 120 mg/po take one tablet once a day

Other names: BR-A-657-K

Primary outcomes

  1. Improvement of carotid radial strain value

    Time frame: 24 weeks

    Improvement of carotid arterial stiffness measured by echocardiography

Secondary outcomes

  1. Improvement in brachial-ankle pulse wave velocity (baPWV)

    Time frame: 24 weeks

  2. Improvement in augmentation index (AIx)

    Time frame: 24 weeks

  3. Improvement in carotid distensibility

    Time frame: 24 weeks

  4. Improvement in sitting systolic blood pressure (SiSBP)

    Time frame: 24 weeks

  5. Improvement in sitting diastolic blood pressure (SiDBP)

    Time frame: 24 weeks

  6. Improvement in central blood pressure (BP)

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Industry

Registry information

Official study title

A Single-arm, Open, Clinical Study to Evaluate the Effects of Fimasartan on Arterial Stiffness in Patients With Hypertension

Acronym: STIFFNESS

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Dec 30, 2013
Registry last updated
Jul 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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